Pluristem's Cell Manufacturing Facility Marks Major Milestone With German Regulatory Approval of New Scaled-Up 3D Manufacturi...
January 23 2014 - 2:00AM
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell product candidates, today
announced it has received approval from the Paul-Ehrlich-Institute
(PEI), Germany's health authority, to supply cells from its
advanced, fully automated, and proprietary 3D cell expansion
manufacturing platform implemented at its new state-of-the-art GMP
facility. Pluristem's new manufacturing facility has the capability
to efficiently produce over 150,000 doses of PLX cells annually,
which potentially translates into significant economic value.
This marks the first regulatory approval of Pluristem's new
facility where the company has implemented its large scale 3D
bioreactor expansion of placental-derived mesenchymal-like Adherent
Stromal Cells (ASCs). The approval will enable the company to
easily support ongoing trials and enter into multiple clinical
trials using its scale-up capabilities for cell supply. The company
is also in the process of getting approvals from other regulatory
authorities including the US FDA.
"We are very pleased to receive the PEI's approval. Following
our multi-million dollar investment into the development of our
proprietary high-throughput culturing technologies, 3D bioreactors,
and proprietary downstream equipment, the PEI's approval confirms
Pluristem's unique position in the cell therapy industry. Our
proprietary 3D manufacturing process can create commercial
quantities of cells with batch-to-batch consistency, so we are
ready to expand and accelerate our clinical programs," stated Zami
Aberman, Chairman and CEO of Pluristem. "In addition, the very
encouraging results of our Phase I/II trial in muscle injury
conducted in Germany suggest that our unique culturing technology
may contribute to the quality and consistency of PLX clinical
studies."
About Pluristem's 3D Manufacturing
Pluristem's state-of-the-art manufacturing site is located in
MATAM industrial park, in Haifa, Israel and is equipped with 500
square meters of clean rooms in which cells can be manufactured to
support clinical trials and for commercial demand at time of
regulatory approval. Pluristem develops and manufactures its
products in full compliance with international quality standards,
including U.S. Food and Drug Administration (FDA), European
Medicines Agencies (EMA), current Good Manufacturing Practices
(cGMP) requirements and International Conference on Harmonization
(ICH) quality guidelines. Pluristem believes that controlling the
process is the key to success and therefore invests major efforts
in developing highly efficient, cutting-edge culturing systems
enabling advancement of its large PLX cell therapy product
candidate's pipeline.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of
placenta-based cell therapies. The Company's patented PLX
(PLacental eXpanded) cells are a drug delivery platform that
releases a cocktail of therapeutic proteins in response to a host
of local and systemic inflammatory and ischemic diseases. PLX cells
are grown using the company's proprietary 3D micro-environmental
technology and are an "off-the-shelf" product that requires no
tissue matching prior to administration.
Pluristem has a strong intellectual property position,
company-owned GMP certified manufacturing and research facilities,
strategic relationships with major research institutions and a
seasoned management team. For more information visit
www.pluristem.com, the content of which is not part of this press
release.
The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and federal securities
laws. For example, we are using forward-looking statements when we
discuss expected regulatory approvals for our manufacturing
facility, or when we discuss the capabilities of this facility and
how they potentially translate into significant economic value,
when we discuss how the received regulatory approval will enable us
to support ongoing trials and enter into multiple clinical trials
using our capabilities for cell supply, when we discuss expanding
and accelerating our clinical programs, or when we say discuss our
belief that controlling the manufacturing process is key for
success and that our culturing technology may contribute to the
quality and consistency of PLX clinical studies. These
forward-looking statements and their implications are based on the
current expectations of the management of Pluristem only, and are
subject to a number of factors and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. The following factors, among others,
could cause actual results to differ materially from those
described in the forward-looking statements: changes in technology
and market requirements; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our
products may not be approved by regulatory agencies, our technology
may not be validated as we progress further and our methods may not
be accepted by the scientific community; we may be unable to retain
or attract key employees whose knowledge is essential to the
development of our products; unforeseen scientific difficulties may
develop with our process; our products may wind up being more
expensive than we anticipate; results in the laboratory may not
translate to equally good results in real surgical settings;
results of preclinical studies may not correlate with the results
of human clinical trials; our patents may not be sufficient; our
products may harm recipients; changes in legislation; inability to
timely develop and introduce new technologies, products and
applications; loss of market share and pressure on pricing
resulting from competition, which could cause the actual results or
performance of Pluristem to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Pluristem undertakes no obligation to
publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. For a more detailed
description of the risks and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time
with the Securities and Exchange Commission.
CONTACT: Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH
Director of Investor Relations
1-914-512-4109
karinek@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com
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